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Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

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ClinicalTrials.gov Identifier: NCT00280917
Recruitment Status : Completed
First Posted : January 24, 2006
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: CF101
Enrollment 254
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CF101 0.1mg CF101 1mg CF101 4mg Placebo
Hide Arm/Group Description CF101 0.1 mg q12 hours orally CF101 1mg q12 hours orally CF101 4mg q12 hours orally Matching placebo q12 hours orally
Period Title: Overall Study
Started 65 63 63 63
Completed 63 57 57 61
Not Completed 2 6 6 2
Reason Not Completed
Adverse Event             1             1             4             1
Change Therapy             1             2             0             0
Withdrawal by Subject             0             2             0             1
Noncompliance             0             1             2             0
Arm/Group Title CF101 0.1mg CF101 1mg CF101 4mg Placebo Total
Hide Arm/Group Description CF101 0.1 mg q12 hours for 12 weeks CF101 1 mg q12 hours for 12 weeks CF101 4 mg q12 hours for 12 weeks Matching Placebo q12 hours for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 65 63 63 63 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 63 participants 63 participants 63 participants 254 participants
54.7  (12.02) 54.3  (9.98) 54.4  (10.07) 53  (10.86) 54.1  (10.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 63 participants 63 participants 63 participants 254 participants
Female
49
  75.4%
46
  73.0%
52
  82.5%
52
  82.5%
199
  78.3%
Male
16
  24.6%
17
  27.0%
11
  17.5%
11
  17.5%
55
  21.7%
1.Primary Outcome
Title ACR Efficacy Criteria
Hide Description ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CF101 0.1 mg CF101 1 mg CF101 4 mg Placebo
Hide Arm/Group Description:
CF101 0.1 mg q12 hours for 12 weeks
CF101 1 mg q12 hours for 12 weeks
CF101 4 mg q12 hours for 12 weeks
Matching placebo q12 hours for 12 weeks
Overall Number of Participants Analyzed 63 57 57 61
Measure Type: Number
Unit of Measure: participants
63 57 57 61
2.Secondary Outcome
Title ACR Criteria Components
Hide Description ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components [tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR], Disease Activity Score (DAS28), and duration of morning stiffness.
Time Frame 12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Safety
Hide Description Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CF101 0.1mg CF101 1mg CF101 4mg Placebo
Hide Arm/Group Description CF101 0.1 mg given orally q12h for 12 weeks CF101 1 mg given orally q12h for 12 weeks CF101 4 mg given orally q12h for 12 weeks Matching placebo
All-Cause Mortality
CF101 0.1mg CF101 1mg CF101 4mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
CF101 0.1mg CF101 1mg CF101 4mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/63 (3.17%)   2/57 (3.51%)   2/57 (3.51%)   0/61 (0.00%) 
Eye disorders         
Visual Disturbance [1]  1/63 (1.59%)  0/57 (0.00%)  0/57 (0.00%)  0/61 (0.00%) 
Infections and infestations         
PNEUMONIA VIRALIS [2]  0/63 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/61 (0.00%) 
hepatitis acute [3]  0/63 (0.00%)  0/57 (0.00%)  1/57 (1.75%)  0/61 (0.00%) 
Supposition of Chronic Bronchitis [4]  0/63 (0.00%)  0/57 (0.00%)  1/57 (1.75%)  0/61 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Non small cell lung cancer [5]  1/63 (1.59%)  0/57 (0.00%)  0/57 (0.00%)  0/61 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
COPD EXACERBATION [6]  0/63 (0.00%)  1/57 (1.75%)  0/57 (0.00%)  0/61 (0.00%) 
[1]
Visual Disturbance
[2]
PNEUMONIA VIRAL
[3]
Hepatitis B
[4]
Bronchitis Chronic
[5]
Non small cell lung cancer recurrent
[6]
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CF101 0.1mg CF101 1mg CF101 4mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pnina Fishman, PhD
Organization: Can-Fite Biopharma
Phone: 011972 39241114
EMail: pnina@canfite.co.il
Publications:
Layout table for additonal information
Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00280917    
Other Study ID Numbers: CF101-202RA
First Submitted: January 23, 2006
First Posted: January 24, 2006
Results First Submitted: February 24, 2015
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015